Friday, April 30, 2010

"The United States governmental entity responsible for alerting and protecting the American public from threats to their health is the Centers for Disease Control, better known as the CDC. The CDC’s mission is to collaborate to create the expertise, information, and tools that people and communities need to protect their health – through health promotion, prevention of disease, injury and disability, and preparedness for new health threats.

Yet, one to four million Americans still suffer from a poorly understood, debilitating disease which was first identified in the United States in three separate recorded outbreaks over 25 years ago, including:

Incline Village, NevadaLyndonville, New York andMiami, Florida.

The individuals who became ill that year came from various economic classes, different age groups, including children and adults and affected people in a small rural town, a large lakeside community and a huge metropolitan area. The individuals in those outbreaks all exhibited the same complex symptoms, yet none of the patients were examined by the government employees who were sent to investigate.

The doctors who alerted the CDC were not told of the other communities in the United States experiencing the same phenomenon. Despite the serious concerns about the severity of the patient’s symptoms and their rapid decent into disability, the CDC refused to investigate further. The CDC concluded that this was a new form of EBV mono. They convened a meeting, in which they decided to call this illness “chronic fatigue syndrome” rather than adopt the name that was being used in the UK: myalgic encephalomyelitis (M.E.). M.E. at that time was already a well characterized infectious neurological disease causing a similar complex illness.

Thus began a twenty five year battle between patients and doctors who fully realized the severity of this illness and a government that has yet to commit an appropriate level of financial resources to aid the discovery process necessary to help individuals with this disease. Not only has the lack of adequate resources been a major road block to discovery, but the CFS scientific review committees are currently ill-equipped to review many of the biologically complex scientific grant requests. Attempts to engage in biological research by basic researchers from virology and retro virology have generally been turned down in favor of studies aligned with a psychological theory of illness.

Years of misdirected research have resulted in a lack of a medical specialty for this group of patients to rely on for expert care. Doctors have been left without adequate knowledge and the tools to effectively care for their patients. The sick have been turned away by major medical centers, ignored by government, and their claims denied by insurance companies who refuse to pay for diagnostic tests and experimental treatments.

How could this happen to such a large group of sick people in this day and age of modern medical technology? Who could possibly benefit by this inhumane treatment of sick human beings?

My husband is fond of the quote made popular in the Watergate era: “follow the money”. His take on it is more specific: When something doesn’t seem right, “follow the money”.

So if one follows the money in this case, we can perhaps begin to unravel the mystery of this crime against humanity. We know that when this disease was first reported to our governmental authorities, another more deadly illness had recently been identified, HIV-AIDS. Our nation was debating how to approach this new “gay man’s disease”, until it struck a young child and a famous athlete, neither who were gay. Countries around the world were struggling to meet the heavy demands of HIV, when myalgic encephalomyelitis began to take its equally heavy toll on the lives of the innocent.

But this disease was a disease that apparently could be ignored. It seemed to impact mainly woman. There was no immediate organ damage that could be detected. It did not kill the afflicted rapidly enough; it only caused a profound disability that could last a life time.

However, a life time of disability requires a life time of disability payments and huge medical bills; something no government or private health insurance provider wants to be responsible for. The only way to avoid medical and disability payments for the sick is to claim the illness is due to a psychological disturbance or mass hysteria, blame the patient for their illness and offer cheap psychological treatment and exercise therapy. As long as no one discovers the true cause of the disease, these entities are safe from any expectation of actual medical intervention. A physical disease may remain in the psychiatric domain if it is called a psychosomatic illness; “meaning a disorder in which mental factors play a significant role in the development, expression, or resolution of a physical illness.”

Despite years of private research and thousands of papers describing the physical deficits found in these patients with this illness, our government and medical entities continue to ignore the evidence in favor of those who espouse a simplistic psychological theory of illness.

But those who stand to gain by misdirecting research funding can not stop the truth from being revealed. What greater evidence is required to support the request for responsible action than the finding of a new human retrovirus replicating in this population of patients? Knowing the significance of this discovery, why has the US government not asked CFS patients to stop donating blood until the cause of this disease is better understood?

Prostate cancer and XMRV research has been made a priority at the National Cancer Institute and major universities as evidenced by the publication of new findings. Yet, there has been no such commitment by those at the National Institute of Allergy and Infectious Disease. Why is this?

Are we to blindly and meekly accept that those who suffer from XMRV (who have been inappropriately branded as having a fatiguing illness called “CFS”) are undeserving of the same medical care afforded others infected with a retrovirus?

I believe this is not time to end the CFSAC but rather a time for the CFSAC to exhibit its commitment by sending its strongest recommendations to the Secretary of Health and following those recommendations with actions:

• Educate the research and medical communities about the number of individuals impacted and the severity of this disease. Recommend that the CDC define ME by the immunological and neurological abnormalities that exist, the many co-infections that are frequently found and the physical complications of this long term illness. It is time to agree on a proper name for this disease and to reflect the most current scientific knowledge in the definition of this disease.

• Seek congressionally mandated research dollars that more closely match the number of individuals impacted by the disease and the severity of the illness. Millions of Americans are ill with ME and yet the NIH allocates a mere $1.00 to $4.00 per year per person. The loss in economic dollars is conservatively estimated to be $9 billion per year. With that kind of economic loss to our society, why isn’t this disease funded at the level of hepatitis C which is currently at $93 million a year? Patients diagnosed with ME also suffer from inflammatory bowel disease, cognitive impairment, fibromyalgia, anemia, gall bladder disease, chronic Lyme disease, sleep disorders, chronic pain, depression, hormonal dysregulation, frequent viral infections, heart disease, and cancer. Yet these sick Americans are forced to seek unproven medical treatments for symptomatic relief due to the lack of scientific understanding of the underlying immune deficiency that is driving this disease.

• Request that research be conducted on XMRV in infectious disease by the NIAID and outside researchers to continue the valuable work begun at the WPI. The human retro virus, XMRV, has been found by WPI researchers in diverse disease populations, including cancer, autism, fibromyalgia, gulf war illness and ME, in men, woman and children. Yet four of WPI’s most recent grants were denied funding on the basis that not enough is known about XMRV to warrant further investigations.

• Create and fund Centers of Excellence in neuroimmune diseases to care for patients with complex disorders caused by infectious agents. Scientific medical criteria should be developed that hold these Centers to standards of performance that include timelines and effectively measure demonstrated outcomes. All such Centers should be interconnected to provide medical consistency in care. They should include research, clinical care and medical education components from classroom lectures, to residencies and fellowships in neuroimmune disease.

• Request a congressional hearing to determine why this disease has been so poorly managed by the CDC and NIH, in order to assure the American public that the failure to recognize a serious threat to the nation’s health will not be repeated.

There is no question that the CFSAC, as defined by its charter, can be an important avenue to a meaningful discourse between those who care about M.E. and those who are capable of initiating action from within the government.

The question is: Has the CFSAC achieved the goals stated in their charter?

The charter states its purpose …..as established to provide science-based advice and recommendations to the Secretary of Health and Human Services and the Assistant Secretary for Health on a broad range of issues and topics pertaining to chronic fatigue syndrome (CFS).

Is this goal being aggressively pursued? Is scientific evidence being reported to the Secretary of Health? What actions have been taken by the Secretary of Health that would provide evidence that this information is being acted upon?

The Function of the committee is stated below:

The Committee shall advise and make recommendations to the Secretary, through the Assistant Secretary for Health, on a broad range of topics including: (1) the current state of knowledge and research about the epidemiology and risk factors relating to chronic fatigue syndrome, and identifying potential opportunities in these areas; (2) current and proposed diagnosis and treatment methods for chronic fatigue syndrome; and (3) development and implementation of programs to inform the public, health care professionals, and the biomedical, academic and research communities about chronic fatigue syndrome advances.

The WPI took the earlier recommendations of this committee seriously. In fact, we built our Institute on the premise that this disease and others very similar to it, deserves “Centers of Excellence” that can bring answers to patients and doctors, in the same manner as multiple sclerosis and muscular dystrophy have successfully done. We believe that to find answers to this complex disease we must combine the translational efforts of basic and clinical researchers working in collaboration with knowledgeable physicians. This is the dream of the WPI: to bring discovery to a disease which has impacted millions of lives, to develop effective treatments and to one day provide preventative measures that will stop the spread of the disease.

This is not something that we can afford to do alone. If this committee will confirm that it is more than a sounding board for frustrated patients and doctors and that it can effectuate the necessary changes in this field, then the WPI fully supports the renewal of its charter.

Martin Luther King, Jr. once said, “The ultimate measure of a man is not where he stands in moments of comfort and convenience, but where he stands at times of challenge and controversy”. I believe that courage is the combination of knowing the right thing to do and then doing it. Please show us you have the courage to make this happen.

Thursday, April 22, 2010

Department of Pathology, University of Utah, Salt Lake City, Utah, United States of America. ila.singh@path.utah.edu

Abstract

BACKGROUND: Xenotropic murine leukemia-related retrovirus (XMRV) is a recently discovered retrovirus that has been linked to human prostate cancer and chronic fatigue syndrome (CFS). Both diseases affect a large fraction of the world population, with prostate cancer affecting one in six men, and CFS affecting an estimated 0.4 to 1% of the population.

PRINCIPAL FINDINGS: Forty-five compounds, including twenty-eight drugs approved for use in humans, were evaluated against XMRV replication in vitro. We found that the retroviral integrase inhibitor, raltegravir, was potent and selective against XMRV at submicromolar concentrations, in MCF-7 and LNCaP cells, a breast cancer and prostate cancer cell line, respectively. Another integrase inhibitor, L-000870812, and two nucleoside reverse transcriptase inhibitors, zidovudine (ZDV), and tenofovir disoproxil fumarate (TDF) also inhibited XMRV replication. When combined, these drugs displayed mostly synergistic effects against this virus, suggesting that combination therapy may delay or prevent the selection of resistant viruses.

CONCLUSIONS: If XMRV proves to be a causal factor in prostate cancer or CFS, these discoveries may allow for rational design of clinical trials.

Wednesday, April 21, 2010

New Zealand's blood banks plan to reject donors with a record of chronic fatigue syndrome (CFS).

The move follows research overseas which has raised concerns about the potential for a recently identified virus XMRV to spread through blood transfusions.

XMRV is a retrovirus, a kind of virus that inserts its genetic map into the cells it infects - something that can have a variety of effects, including killing the cell or turning it cancerous by affecting its genetic makeup.

It was first detected in prostate cancers in 2006 and has been found in 27 percent of such tumours, especially aggressive tumours.

There is now conflicting evidence surrounding a link to CFS, which is also known as ME in New Zealand where there are reported to be 20,000 sufferers.

Canadian authorities have already imposed a lifetime ban on former CFS patients donating blood.

They took the precautionary step earlier this month, based on US research that showed the retrovirus may be transmissible through infected blood.

Across the Tasman, Australia's Red Cross Blood Service is also reviewing its donation guidelines.

The national medical director for New Zealand blood banks, Peter Flanagan, told NZPA the NZ Blood Service (NZBS) would be adopting a similar approach to that being developed by the Canadian blood services.

Tuesday, April 20, 2010

Australia's Red Cross Blood Service is reviewing its donation guidelines after Canada halted donations from people who have had chronic fatigue syndrome (CFS).

Canadian authorities took the precautionary step earlier this month, based on US research that linked CFS to a recently identified virus (XMRV) which would be transmissible via infected blood.

Australia's blood service is conducting its own risk analysis. It says existing donor guidelines require people with CFS to defer giving blood until they make a full recovery.

"We are aware of recent developments in Canada," the Australian Red Cross Blood Service said in a statement on Tuesday.

"We are undertaking our own risk analysis to assess what action, if any, should be taken."

The blood service said it takes more than 500,000 blood donations each year but only 70 donors with CFS had been deferred in the past two years.

It was standard practice to defer all potential donors who were unwell and in the case of people with CFS they needed written advice from their GP before they could be accepted as a donor.

"The blood service currently defers donors who suffer from chronic fatigue syndrome (and) before we can accept their blood again, they need to bring us a letter from their treating physician advising us that they are completely recovered," the statement said.

The Canadian ban on CFS sufferers donating blood is for their lifetime out of concern any viral cause of their CFS could be spread.

XMRV (Xenotropic murine leukaemia virus-related virus) was first detected in prostate tumours in 2006 and there is now conflicting evidence surrounding a link to CFS.

Late last year, a US study of blood samples taken from 101 people with CFS found 95 per cent also showed evidence of XMRV infection but following studies have not produced the same results.

Saturday, April 17, 2010

This press release was issued yesterday 2010/16/04 in The Netherlands bij dutch jounalist Toine de Graaf. Here is an English translation.

Gendringen, 2010/04/16 - Researchers at UMC St. Radboud announced in February no XMRV virus has been found in the blood of Dutch chronic fatigue syndrome (ME/CFS) patients. They concealed, however, that U.S. reseachers did found traces of this retrovirus in blood samples of the same patient. This is shown in a web publication of Ortho magazine, which is put online today.

For years medical researchers have been searching for the biological cause of CFS, but always without success. Last October Americans announced a breakthrough: researchers from the Whittemore Peterson Institute (WPI) in Reno found the retrovirus XMRV in many patients with ME/CFS. The study was published in the leading scientific journal Science, after a Research period of 2.5 years.

Researchers at UMC St. Radboud had doubts and decided to repeat the Science research, with frozen blood samples from Dutch patients from 1991-1992. The study took place very rapidly under the leadership of Nijmegen experimental virologist Dr. Frank Kuppeveld and internist Professor Dr. Jos van der Meer. But they found nothing. "Neither in the blood of 32 patients, nor in that of the 43 controls, the retrovirus was found ", the UMC St. Radboud was quoted in a press release issued at the end of last February.

Now it is obvious certain things are concealed. This week a letter has been made public by Annette Whittemore, who directs the WPI. In this letter she describes that the WPI, at the request of Frank Van Kuppeveld, has tested some blood samples from the Dutch cohort study prior to the completion of the Nijmegen study. The WPI found traces of XMRV in these samples. Whittemore says she possesses email correspondence that shows Van Kuppeveld was aware of the WPI research results before the Dutch study was published in the British Medical Journal.

The web publication of Ortho provides a reconstruction of events based on an interview with Dr. Judy Mikovits, Research Director of the WPI. The web publication coincides with the appearance ofthe April issue of Ortho, were further attention is spent on XMRV.

Thursday, April 8, 2010

NEW ORLEANS -- Andy Martin stared so hard at the cells he was examining that the microscope left marks around his eyes.

A third-year medical student, Mr. Martin is a researcher in a cancer lab at Tulane University Health Sciences Center. The cancer cells under scrutiny are the same ones growing inside him -- in his nose, behind his eyes, pressed against his brain.

Mr. Martin, 31 years old, doesn't expect to find a cure for his cancer, sinonasal undifferentiated carcinoma, or SNUC. The disease is almost always fatal. Only 100 cases are documented in the medical literature.

When he was diagnosed, Mr. Martin took up surfing, considered dropping out of school and checked out the price of an air ticket around the world. But then he decided that before he died, he wanted to understand SNUC better. So, for the past six months, while his doctors have been trying to kill the cells that are destroying his body, he has been trying to grow the same cells in the laboratory.

"If I don't study it," he says, "there is no one else that is going to do it."

According to the National Cancer Institute, the most common form of cancer in the U.S. is breast cancer, with 2.2 million people living with the disease in 2000, the latest year for which figures are available. Some 1.6 million have prostate cancer, and another million people have colon and rectum cancer.

While more than $1 billion is spent on cancer research every year, there isn't a lot of money available to do very narrow, specialized research. There was little being done for SNUC. Mr. Martin and other researchers hope that knowledge gained from studying rare cancers such as SNUC may help gain insight into how other cancers grow.

Tuesday, April 6, 2010

"When ME biomedical research and researchers have been starved of funding by the UK Medical Research Council it is particularly galling to hear that the charity AYME's medical advisor, Esther Crawley, is to receive £160,000 from the Linbury Trust and the Ashden Trust to look at the psycho-therapy which is the Lightning process [http://www.bristol.ac.uk/ccah/news/2...esthercrawley].

There are many stories of the damage this series of courses can do to patients - a business enterprise which is unregulated, has no valid research into the "theory" behind it which really warrants funding of it (certainly not in preference to the funding of biomedical research into ME) and for which anyone can seemingly attend a few courses and set up a business, with no medical training.

This reminds us of a similar psychological approach to ME which that same charity discussed in a conference in 2005 - Reverse Therapy (RT) - with their then medical advisor, child psychiatrist Dr Derek Proudlove, who reported on his successful pilot study on RT. Five years on and children with ME are still ill but now we have another expensive training programme attracting the attention of another medical advisor.

We thought to check the definition of a pyramid business - "A successful pyramid scheme combines a fake yet seemingly credible business with a simple-to-understand yet sophisticated-sounding money-making formula which is used for profit".

Those who subscribe to organisations who market, advocate or advertise businesses under the guise of treatments for vulnerable and chronically ill people might reflect on the policy of the charity they are supporting.

If this training programme really needs research then why not start with adults who can give informed consent - and why not test it on a well known patient group with clear biomarkers such as diabetics or MS patients to see if these patients stop "doing" diabetes or MS after three days of training. Why are ME patients always the target for therapy businesses? If there is funding available for research into ME then why not direct it to biomedical research?"

Doctor Speedy:And yes, please try flying to the moon so you GET nearer to the God of Lightning and if he strikes a match and let the ball slip through his hands and that cures you than fantastico.

It is a bit like the Robinson and Carson therapy for Steve McLaren. It cured him of that horrible disease called the England manager’s job alias northern rock to kick against by any tabloid on the island.

And I agree, he was so daft to instruct his goalies, ignore all the evidence that we see on our TV screens on a weekly base that it is better if goalies pick up the ball and hold on to it.

But no, they had done group therapy CBT sessions to improve their perforations in their gloves, or is it performance enhancing drugs that CBT stuff, so illegal as can be than???

You sniff it, snort it, smoke it and then spit it out. Is that how it works and why it is so useless in ME?

Now come to think of it, is CBT not just another way of spelling Cannabis Blowing Treatment, or is that a misconception???

Monday, April 5, 2010

An infectious virus linked to two diseases is drawing the attention of public-health officials, who are investigating the potential threat to the nation's blood supply.

It isn't clear if the virus, known as XMRV, poses a danger, and public-health officials say there isn't evidence of spreading infection. But because of concern over the potential for widespread infection and preliminary evidence that XMRV is transmitted similarly to HIV, officials are quickly trying to determine if action is needed to protect the blood supply.

Thursday, April 1, 2010

"Dear Editor,I refer to ‘Defeatism undermines the treatment of chronic fatigue syndrome’ (26/2/10, www.imt.ie/clinical/infections-immunology/defeatism-undermines-treatment.html). This article trivialises the severity of the illness and contains a number of factual inaccuracies.

NICE is selectively referenced. It actually points out that CFS/ME is a very serious real illness of yet unknown origin and can be more disabling than multiple sclerosis or late-stage AIDS. There is no known cure or effective treatment.

In the words of NICE: “The Guideline Development Group did not regard CBT or other behavioural therapies as curative or directed at the underlying disease process, which remains unknown. Rather, such interventions can help some patients cope with the condition” (CG53 p252). This should have been quoted.

NICE specifically make the point that CBT is not a treatment for the symptoms but an aid to help patients come to terms with their illness. Is this what is meant by ‘working’? CBT has never shown any objective benefit.

Some studies, using self reporting, have shown a subjective benefit on fatigue, i.e. as assessed by the patient, but no effect at all on activity levels when measured scientifically. The confidence intervals in these studies are so wide as to make extrapolation into a general ME/CFS population impossible.

The studies are clearly underpowered. Many sufferers take their lives because living with the symptoms is unbearable.

There is no robust scientific evidence to support GET although there was a recent heart attack! The known and frequent adverse events associated with the GET/CBT combination, have never been scientifically evaluated.

Why were NICE instructed to ignore all the biomedical evidence when drafting their guidelines? Would any pharmaceutical product obtain a product licence based on patient self-evaluation – or with the confidence interval values associated with CBT studies?

The answer is a resounding no! Why, therefore, are sufferers of ME/CFS classified by the WHO as a neurological disorder only offered CBT?

"Plenty of people are still dying of diseases which other people do not believe." (Dr. M.N.C. Dukes).CBT and GET for ME: "There is no nonsense so gross that society will not, at some time, make a doctrine of it and defend it with every weapon of communal stupidity."

Robertson Davies

THE NICEGUIDELINES BLOG VERSUS THE NICEGUIDELINES

These are NOT the NICEGuidelines. This is "The NICEGUIDELINES BLOG." What are the differences:

The NICE Guidelines are biased publications based on the GOBSART (Good Old Boys Sitting Around a Table) approach.

This Blog however is not only evidence based but also uses critical reading to judge papers and articles. I also use common sense and listen to others. And finally I read both psychiatric and medical evidence and opinions from around the world to come to a conclusion.

I’m not sponsored by anybody or paid by whatever company as seems to be the norm with many psycho people who publish the same article almost on a weekly base.

So if you value an opinion, formed as a result of participating in many ME activities, for example being bed bound for years, you have come to the right BLOG. All these activities have allowed me to form an opinion as a Doctor and as a Patient. And that is important as the voice of the latter is discarded by many including NICE.

If you don’t read this blog, you will miss out on “accredited” medical education. If you do read it, you may actually become a doctor who doesn’t stop thinking or forgets to ask critical questions. Many good things, including satisfied patients are at your command.

So, if you arrived here for the straightforward GOBSART approach, I will disappoint you. If you are interested in forming your own opinion about ME, and other interesting things, read on!

About Dr. Speedy.

I am a Family Physician or GP as it is called in Australia or the UK. I am also an ME patient unfortunately. Bedbound that is. So at the moment I’m in private practice so to speak. I’ve got only one patient, ME, or is it me?

I graduated as a doctor a long time ago, and I am the founder and editor of The NICEGUIDELINES BLOG, an internet based ME BLOG that is devoted to critical reading and cheering you or ME up.

I have the following conflict of interest: I would like to get better and see that the wasting of public money on CBT (talk therapy for a neurological disease, really helpful) and other silly therapies for ME stops, and will be used in better ways.

My goal has always been to help, and if possible, cure patients. With this disease you will soon find out that many psychiatrists and psychologists are only in it to make money and get their name in the spotlight. And what happens to and with the patients is irrelevant.

I stand to benefit both mentally, physically and also financially if this silliness would stop, and I would get my health back, and I can go back to work and have a normal life again. Please evaluate my postings with this in mind! And remember, there are also (lots of) psychiatrists and psychologists who haven’t switched their brain off.